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Testing the Pain Relief of musculOskeletal Conditions and Arthritis Using Culturally Tailored InterVentions for Black Elders (PROACTIVE) Intervention: A Randomized Controlled Trial
Chronic musculoskeletal pain (CMP), while a leading cause of physical disablement, is a neglected national health disparity issue in Black communities. The purpose of this study is to test a novel culturally congruent pain self-management intervention. A total of 120 persons aged 50-92, self-identifying as Black or African American having CMP will be invited to participate in this study. The primary outcome measured throughout this 3-year study is movement-evoked pain (MEP).
Chronic musculoskeletal conditions and their primary source of pain, movement-evoked pain (MEP), causes significant pain interference, long-term mobility impairment, healthcare costs, and psychosocial inequalities. MEP affects more Black/African Americans (B/AAs) and is reported as more severe than in White participants. Compounded by race, age, and more disadvantageous social determinants of health (SDoH), this unequal burden of pain becomes even greater in health disparity populations like older B/AAs. Many B/AA older adults rely on non-pharmacological pain self-management (SM) strategies. Yet, current chronic musculoskeletal pain (CMP) SM interventions do not measure MEP as a primary endpoint nor address faith/spirituality, Black culture, and other underlying potentially modifiable SDoH (e.g., health literacy, financial hardship). The investigator team propose to enhance older B/AAs' capacity to manage MEP by investigating the effects of a socioculturally congruent pain SM intervention (Pain Relief for musculOskeletal conditions and Arthritis using Culturally-Tailored InterVentions for Black Elders \[PROACTIVE\]). This intervention will provide culturally congruent pain SM education with a SM resource toolkit, active prayer skills, and financial counseling to explain participants' healthcare/insurance benefits for pain care. This study will enroll 120 B/AAs (50 years and older) with CMP into a parallel group, single-blind, randomized controlled trial to test whether PROACTIVE decreases MEP in the immediate post-intervention period (n= 60) (Aim 1) and over time (Sub-Aim 1a) compared to a usual care control group (n= 60). To determine efficacy, this study will use state-of-the-art and real-time technologies to measure primary outcome as well as pain interference, pain coping, and physical function (secondary outcomes) (Sub-Aim 1b). The PROACTIVE group will work with a faith-community nurse and financial counselor over four weeks to enhance knowledge of CMP SM, utilization of active prayer and faith, and financial literacy of health insurance benefits and resources available to cover treatments for pain. Each weekly session will last up to 2 hours and will be followed by six days of ecological momentary assessments of pain and SM outcomes and ecological momentary interventions guiding participants through weekly SM practice skills. A fourth booster session will reinforce content and training and help sustain SM. Another goal is to examine the differential effects of PROACTIVE on MEP according to demographic (sex as a biological variable, gender, age), psychosocial, and SDoH factors (Aim 2). The proposed intervention is expected to produce meaningful reductions in MEP in B/AA older adults experiencing disabling chronic musculoskeletal conditions. Ideally, this study will identify precision behavior targets and responders to inform intervention refinement. This study is innovative because it: (1) addresses three key social determinants of health central to B/AAs' pain experience- health literacy, faith, and finances, (2) embeds community-engaged research methodologies, (3) tests active prayer as a novel faith-based, culturally relevant intervention, (4) uses real-time ecological momentary assessment (EMA) to measure pain and related outcomes and use just-in-time ecological momentary interventions (EMI) to deliver pain SM decision support and active prayers, and (5) measures MEP as a primary endpoint in a clinical trial.
Age
50 - 92 years
Sex
ALL
Healthy Volunteers
No
University of Florida
Gainesville, Florida, United States
Start Date
May 7, 2025
Primary Completion Date
August 1, 2027
Completion Date
October 1, 2027
Last Updated
May 9, 2025
120
ESTIMATED participants
PROACTIVE Intervention
BEHAVIORAL
Lead Sponsor
University of Florida
Collaborators
NCT07153471
NCT07351968
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06747494